Taiwan FDA registration b1f9af75a40cf7ed98402b17d6e0bbff

and photoalpha-fetoprotein concentration and its heterogeneous (AFP-L3) ratio determination correction solution and quality control solution

TW: 和光甲胎蛋白濃度及其異質體(AFP-L3)比率測定校正液及品管液
Taiwan flagTaiwan·Risk Class 2·FUJIFILM Wako Pure Chemical Corporation Mie Plant·Registered Jun 13, 2023 – Jun 13, 2028Active
Registration details
Analysis ID
b1f9af75a40cf7ed98402b17d6e0bbff
Customs Code
DHA05603618806
Company information
Manufacturer Country
Japan
Authorized Representative
MEDICARE PRODUCTS INC.
Product details
Intended Use
Calibration Solution: This product is designed to correct μTASWako AFP-L3 reagent for the quantitative determination of AFP-L3% and AFP in human serum. Quality control solution: This product is designed as a quality control material for the quantitative determination of AFP-L3% and AFP in human serum with μTASWako AFP-L3 reagent.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration
Import Information
QMS/QSD;; 輸入
Dates and status
Registration Date
Jun 13, 2023
Expiry Date
Jun 13, 2028
About this record

Access comprehensive regulatory information for and photoalpha-fetoprotein concentration and its heterogeneous (AFP-L3) ratio determination correction solution and quality control solution in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number b1f9af75a40cf7ed98402b17d6e0bbff and manufactured by FUJIFILM Wako Pure Chemical Corporation Mie Plant. The authorized representative in Taiwan is MEDICARE PRODUCTS INC..

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